Purpose

This program equips professionals and organisations with the knowledge and skills to establish and maintain effective Quality Management Systems (QMS) for medical devices. Learn to implement best practices, comply with regulations, and manage risks throughout the product lifecycle.

Audience

This course is ideal for professionals seeking to:

• Implement robust QMS: Develop expertise in quality management systems specifically for medical devices.
• Navigate regulations: Gain knowledge and skills to comply with relevant regulations in the medical device industry.
• Ensure patient safety: Contribute to the development and production of safe and effective medical devices.

Benefits

Effective quality management in medical devices helps to:

• Improve patient safety: Ensure the safety and efficacy of medical devices through robust quality practices.
• Comply with regulations: Meet regulatory requirements specific to the medical device industry.
• Minimise risks: Proactively identify and manage risks associated with medical device development, manufacturing, and distribution.
• Enhance product quality: Maintain quality and compliance throughout the entire product lifecycle.

Outcome

This program EMPOWERS you to:

• Become an expert in medical device quality: Gain a deep understanding of ISO 13485 principles, requirements, and core concepts for quality management in the medical device industry.
• Implement the standard effectively: Learn practical strategies to apply ISO 13485 within your organisation and improve your medical device quality management system.
• Navigate regulatory requirements: Understand regulations associated with medical devices and how ISO 13485 compliance can help you meet them.
• Manage risks effectively: Develop skills to identify, assess, and manage risks throughout the medical device lifecycle, from development to distribution.
• Ensure product quality throughout the lifecycle (optional): Gain guidance on managing the entire product lifecycle, ensuring quality and compliance from design to post-market activities (often included in the training).

Course Details

FQA offers its Certification exam and self-study/blended Training courses at 3 levels (Foundation, Specialist, Professional). To understand more about the 3 levels, click here

For the ISO 13485:2016 Medical Devices Quality Management self-study/blended Training Courses, we suggest that you choose the course which is the same level as the above Exam. For detailed information, please access:

• Foundation level training course
• Specialist level training course
• Professional level training course